Statement of Work Project Title: Biostatistics Consulting Services Department: National Institute of Neurological Disorders and Stroke Office of Translational Research (OTR) NINDS Requiring Official: Chris Boshoff, Ph.D, Scientific Project Manager Office of Translational Research (OTR), NINDS Background: The National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Unit (CTU) staff work with investigators at the NINDS Division of Intramural Research (DIR) in specific neurological and clinical research areas, including protocol development of interventional and non-interventional clinical research studies for neurological disorders and stroke. In addition to advising intramural investigators in the conception, development, implementation, and execution of clinical research studies and clinical trials, CTU interacts with the extramural Offices of Translational Research (OTR) and Clinical Research (OCR) to support the mission of NINDS. The CTU provides expertise to NINDS and investigators in the conception, design, implementation, execution, analysis, and reporting of clinical research. CTU staff advises the investigators and the Institute on clinical research methodology, research ethics, safety monitoring, clinical research data sharing, clinical trial reporting, and gender and minority tracking. For extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. The NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through nonclinical development and early clinical investigation. NINDS seeks statistical advice given the institute?s high priority in increasing the predictive value of non-clinical research, in order to ensure therapy projects are moving ahead to the clinic for the right reasons. For more information on the Office of Translational Research, Extramural program visit the website: http://www.ninds.nih.gov/funding/areas/translational_research/index.htm Purpose or Objective of the Requirement The purpose of this acquisition is to procure biostatistics consulting services for the NINDS CTU and extramural research community. Level of Effort The level of effort is estimated at one (1) contractor employee for sixty (60) labor hours during the period of performance of this purchase order. Scope of Work The Contractor shall provide the following Biostatistics Consulting Services: ? Provide expert and strategic biostatistical technical support, guidance, and advice on advancing Government projects through nonclinical and clinical development. ? Prepare and review statistical analysis plans, provide detailed specifications for analysis files, consistency checks, tables and figures; communicate with Government staff and investigators regarding statistical design and analysis issues. ? Prepare process optimization and validation plans upon request. ? Evaluate the design of Government studies and milestones for sound statistical analysis plans to ensure they are sufficiently powered and controlled with experimental and statistical rigor to lend a high degree of confidence in the studies and results. ? Interpret and, as needed, perform analyses and assist in the writing of statistical sections of study reports. ? Explain statistics in plain language. ? Provide feedback and recommendations of a biostatistics nature on projects through written documents, conference calls, and by email. Provide technical review and feedback of a biostatistics nature regarding project milestones, progress reports, development plans, study design, and data interpretation. ? Interact with Federal staff and clinical trial investigators to provide scientific information in support of Government research strategy with regards to statistical methods for trials as the Government prepares protocol and grant applications. Key Personnel Requirements The Contractor employee working under this award shall be considered key personnel. Key Personnel requirements are as follows: ? A PhD in a biostatistical discipline is preferred ? At least 10 years biostatistical experience in the biotechnology or academic sector ? At least 5 years demonstrated experience in: o Design and review of nonclinical animal research plans and/or analysis of nonclinical animal research results for IND-enabling studies or clinical studies o Design of clinical trial protocols, innovative and adaptive designs, review of statistical analysis plans, and validations plans. o Statistical interpretation of published results or critique of scientific proposals o Statistical support to non-clinical and/or clinical development efforts The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows: The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The following individual(s) is/are considered to be essential to the work being performed here under: Name Title To be determined in the contract award Biostatistics Consultant Type of Contract A firm fixed price purchase order within the Simplified Acquisition threshold is anticipated. Period of Performance The period of performance shall be from March 21, 2016 ? September 30, 2016 Place of Performance The contractor shall provide services remotely from its own site. Government Furnished Property/Information No Government furnished property shall be provided. Project related data will be provided to the contractor for performance of work efforts. All data provided to consultant must be treated as confidential and not be disclosed to any third party. Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the COR for approval to store data longer. NINDS requires that the consultant?s meet certain minimum requirements: All computers that are used by the consultant to perform work under this contract whether contractor furnished or government furnished will have to have: ? Virus protection with regular automated scans ? Up to date security patching ? Two factor authentication ? Encryption - FIPS 140-2 compliant encryption solution ? Regular vulnerability scans and if the scan produces any high or medium results they need to be corrected - highs within 30 days and mediums within 90 days ? Contractors will have to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/ ? Consultant will have to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf ? Report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a contractor furnished computer. ? Contractors must adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx Travel Travel is not required or authorized for this contract. No travel costs shall be reimbursed. Collaboration: It is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer?s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Confidential Treatment of Sensitive Information Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. The NINDS has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature. Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information. Data Rights: The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of ?unlimited rights? is contained in Federal Acquisition Regulation (FAR) 27.401, ?Definitions.? FAR clause 52.227-14, ?Rights in Data-General,? is hereby incorporated by reference and shall be made a part of any resulting contract/order. Non-Personal Service Statement: Contractor employees performing services under this order will maintain the patient?s privacy act under the ?HIPA? laws. Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR). Evaluation Criteria The Government will award a purchase order resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows: Factor Weight Factor 1: Technical Capability The Contractor?s proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. 50 Factor 2: Key Personnel Qualifications Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV. 25 Factor 3: Past Performance The Contractor shall provide a list of two (2) past performance references with knowledge of the contractor?s relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information: a. Name of Organization b. Description of Contractor?s responsibilities as they relate to this SOW c. Contract Period of Performance d. Contact Name and Title e. Telephone Number f. E-mail address Past Performance shall be evaluated for relevance to the current requirement. 25 Additional Applicable Terms and Conditions FAR 52.227-14 Rights in Data-General (May 2014) is applicable to this requirement. HHSAR 352.224-70 Privacy Act (December 18, 2015) is applicable to this requirement. HHSAR 352.237-75 Key Personnel (December 18, 2015) is applicable to this requirement. Independent Government Cost Estimate The cost of this requirement is estimated at $8,400.00. This estimate is based on a fully loaded hourly biostatistics consultant labor rate of $140.00 for 60 hours during the award period of performance. Requiring Office National Institute of Neurological Disorders and Stroke Dr. Chris Boshoff 6001 Executive Boulevard, Room 2151 Rockville, MD 20852 Contracting Officer Representative Chris Boshoff Ph.D 6001 Executive Blvd. Suite 2152 Bethesda, MD 20892-1620, USA E-mail: chris.boshoff@nih.gov Telephone: 301.496.0664 The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this purchase order; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this purchase order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this purchase order; (5) otherwise change any terms and conditions of this purchase order; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in the purchase order. The Government may unilaterally change the COR designation for this purchase order.